Market Leaders in Comparator Sourcing & Other Specialty Services

THE CLINIGEN DIFFERENCE

As market leaders in Comparator Sourcing, Clinigen offers smart and flexible strategies to provide you with unrivalled access to medicines and ancillaries, as well as direct access to a global network of manufacturers, audited third-party suppliers, and approved distributors.

Clinigen’s efficient sourcing capabilities provide you with access to comparator drugs, standard of care and adjuvant therapies, reference listed drug (RLD) samples, rescue medications and ancillaries for use in clinical trials. With our exclusive and preferred-partner relationships with manufacturers, we offer valuable local and global knowledge across the manufacturer landscape.

The support of our industry-leading team of account managers, specialist sourcing experts, and the biggest regulatory team in the field combined with the consultancy and technical guidance from our experts of QPs, physicians, and pharmacists ensures we have access to the broadest range of branded and generic medicines; thereby removing the burden of navigating complex quality and regulatory requirements.

As a dedicated global depot and logistics network with local, regional, and central sourcing and supply capabilities, the entire Comparator sourcing team at Clinigen works to ensure your medicines get to sites quickly, on time, in the right quantities, and accurately packaged and labelled.

 

Flexible sourcing strategies

At Clinigen, we offer flexible Comparator Drug Sourcing strategies that can range from:

  • Traditional bulk purchases of comparator product, on a lead time of serval months, and sourced from a single location with an appropriate flexible packaging, labelling and distribution strategy,
  • Sourcing your product ‘on-demand’, providing smaller quantities on a more frequent basis but allowing for greater flexibility to adjust forecasts that are in line with the ever-changing needs of your clinical trial, 
  • ‘Rapid-source’ for the swift sourcing of product in smaller quantities to meet unexpected patient demand, a shipment held up at customs, or even a site temperature excursion and combined with an ‘On-Demand’ labelling strategy.

The on-demand consignment model

Speed and flexibility in your supply chain are crucial to the success of your clinical trial. This is why Clinigen has partnered with Accord Healthcare to provide an exclusive ‘On-Demand’ service that provides instant access to key EU generic oncology products, eliminating long lead times.​ Clinigen and Accord have been partners since 2012 in the delivery of oncology injectable and solid dose products. Products are held in large batch sizes on consignment ready for instant dispatch to new and existing clinical trials. Our On-Demand supply service with Accord Healthcare is operating from both the UK and France, to service our global client base.

 

From exclusive distribution agreements to On-Demand sourcing, we pioneer new supply strategies to help your trial run as efficiently as possible.

 

on-demand sourcing service pathway chart

 

From exclusive distribution agreements to On-Demand sourcing, we pioneer new supply strategies to help your trial run as efficiently as possible.

 

Clinigen's other Specialty Services

Our market-leading position in Comparator Sourcing, as well as our long-standing experience with our specialty services like On-Demand Packaging & Labelling, Investigator-Initiated Studies (IIS), and Direct-to-Patient (DtP) services is what makes Clinigen Clinical Supplies Management stand out.

 

On-demand packaging & Labelling

Our Clinical Supplies Management team can work with you to start a new clinical trial with quick turnaround times and can process new shipment requests or make changes to the trial within 48 to 72 hours. This flexibility allows you to save costs, use your drug product in multiple protocols, and avoid waste. Expensive and limited supply medicines can greatly benefit from the On-Demand method. Learn more about our On-Demand services.

 

Direct-to-patient

With over a decade of experience in managing Direct-to-Patient (DtP) studies, we have delivered over 7000 DtP shipments to trial patients to date. A traditional trial can be turned into a DtP trial either partly or completely. We also provide site to patient shipments, and can adapt your trial quickly, as needed. Benefits include reducing the number of patient drop-outs and the overall cost of a study, as well as access to a Wider Patient Population. Learn more about our Direct-to-Patient services.

 

IIS SERVICES

Thanks to our decades of experience providing Investigator-Initiated Studies Services, our unique perspective enables us to provide smart and flexible processes that operate as if they were outside of a clinical study. When it comes to distribution, we have managed regulatory pathways required to facilitate the movement of materials in support of the IIS and EAP programs on an international level. Learn more about our IIS services.

 

biological sample management

With over 20 years of experience in biological sample management, Clinigen’s pioneer services reduce costs while maintaining the required quality of your biological samples. We handle more than biorepository services, samples logistics, and sample collection kit design and assembly. We also offer sample de-identification, consultations, and project management services. Our staff has served clients in academia, pharmaceuticals, biotechnology, and central laboratories. Learn more in our Guide to Biological Sample Management

 

QP SERVICES

Clinigen Clinical Supplies Management focuses on providing the best Qualified Person (QP) services for your clinical trial supply needs. A QP is primarily responsible for ensuring that the clinical product in a study has been manufactured and/or imported in accordance with EU GMP or equivalent criteria. Our certified QPs can support both EU and UK drug product release and batch certification, mitigating any Brexit-related risk for your clinical trial. Learn more about our QP Services.

Testimonial

Success stories

“On behalf of my team, I would like to express our sincere thanks to Clinigen for your extraordinary work and dedication. We would not have been able to meet our clinical program goal without your heroic effort.”

Vice President of Technical Operations, BioPharma Company

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As market leaders in Comparator Sourcing, Clinigen offers smart and flexible strategies to provide you with unrivalled access to medicines and ancillaries. From exclusive distribution agreements to On-Demand sourcing, we pioneer new supply strategies to help your trial run as efficiently as possible and eliminate long lead times.​